Model Number 27023 |
Device Problem
Device Stops Intermittently (1599)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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The device was returned to resmed for an extensive engineering investigation.The investigation methods, results, and conclusion are not finalized at this stage.When more information is available a supplemental report will be submitted.(b)(4).
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Event Description
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It was reported to resmed that an astral device powered down unexpectedly while using its internal battery.There was no patient harm or serious injury reported as a result of this incident.
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Event Description
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It was reported to resmed that an astral device powered down unexpectedly while using its internal battery.There was no patient harm or serious injury reported as a result of this incident.
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Manufacturer Narrative
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The astral device was returned to resmed for an investigation.Review of the device data logs confirmed the reported device unexpectedly powering down while using its internal battery.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the root cause was an isolated component failure within the device battery assembly.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.(b)(4).
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Search Alerts/Recalls
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